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Medimaging Integrated Solution Inc.(Dongguan)

✓ Record-verifiedregistrations found in 10 marketsEU SRN TW-MF-000009317Unified social credit code 91441900310566552C

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, South Korea, Australia, Hong Kong — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

4China registrations

Class I 2Class II 2

as of 2026-09-04

EUEuropean UnionEUDAMED

38UDI-DI device records

Class I 24Class IIa 14

USUnited StatesFDA openFDA

21listed device types

Class I 13Class II 8Class III 0

plus 23 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class I 4Class IIa 4

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

6registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union40 raw hits, 2 excluded, 38 confirmed

United States23 registration records, 9 510(k), 0 PMA

China4 certificates (Class III 0 / II 2 / I 2), as of 2026-09-04

United Kingdom8 confirmed, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia6 confirmed, 0 excluded

Manufacturer names merged into this page: MEDIMAGING INTEGRATED SOLUTION INC. · Medimaging Integrated Solution Inc.as trading as Medimaging Integrated Solution Inc.(Dongg

Regulatory identity

EU manufacturer SRN: TW-MF-000009317
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Medimap Ltd
Unified social credit code: 91441900310566552C
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2014-09-24
Registered capital: CNY 7,000,000
Paid-in capital: CNY 7,000,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2025-08-15
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12012

12017

12019

12020

12022

22023

12024

12025

FDA listed device types

showing 8 of 21

Tonometer, Ac-Powered 1Nasopharyngoscope (Flexible Or Rigid) 1Bronchoscope (Flexible Or Rigid) 1Camera, Ophthalmic, Ac-Powered 1Cystoscope And Accessories, Flexible/Rigid 1Arthroscope 1Camera, Ophthalmic, General-Use 1Biomicroscope, Slit-Lamp, Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20252160695	光学相干断层扫描仪	Class II
CN	粤械注准20192160996	眼底照相机	Class II
CN	粤东械备20240153	耳镜	Class I
CN	粤东械备20160008号	口腔观察仪	Class I
EU	04719872710080	MiiS Horus Scope	Class I
EU	04719872710073	MiiS Horus Scope	Class I
EU	04719872710066	MiiS Horus Scope	Class I
EU	04719872710035	MiiS Horus Scope	Class I
UK	56654	MiiS horus SCOPE Tablet	Class IIa
UK	56654	VersaVue Cystoscope Tablet - Demo - Global	Class I
UK	18034	MiiS horus SCOPE Video Box	Class IIa
US	K253217	MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)	2025-12-23
US	K234113	MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box	2024-05-01
US	K223739	VS Tabletop Tonometer	2023-11-08
BR	80117589178	VersaVue	Class II
BR	80867159019	Otoscópio Medimaging	Class II
BR	80867159020	Retinógrafo Medimaging	Class II
SA	ME0000006222SFDAA00001	Horus Scope	—
SA	ME0000006220SFDAA00003	Horus Scope	—

Medimaging Integrated Solution Inc.(Dongguan)

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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